Immuno Nutrition by L-citrulline for Critically Ill Patients
- Conditions
- IntubationPulmonary Ventilation
- Interventions
- Procedure: Enteral nutritionDietary Supplement: PlaceboDietary Supplement: L-Citrulline
- Registration Number
- NCT02864017
- Lead Sponsor
- Rennes University Hospital
- Brief Summary
The main objective of this study is to demonstrate that the only administration of L-citrulline, can improve immune functions in critically ill patients at high risk of nosocomial infection.
- Detailed Description
This is a multicentric therapeutic trial, randomized and double blind: standard enteral nutrition plus L-citrulline (5 grams/12 Hours for 5 days from the admission in Intensive Care Unit (ICU)) versus standard enteral nutrition plus placebo.
Methods-Patients: Non-surgical patients admitted in medical intensive care unit, under mechanical ventilation for an expected duration \> 2 days, without severe sepsis or septic shock, will be enrolled. Symptoms leading for ICU admission ongoing for five days maximum. On admission (before treatment), the severity will be evaluated with the Sepsis-related Organ Failure Assessment (SOFA) score together with an assessment of plasmatic arginine, cytokines (InterLeukin-6 (IL6) ), and expression of Human Leukocyte Antigen - antigen D Related (HLA-DR) by monocytes. The same evaluation will be repeated on day 3 (during treatment) and on day 7 (after treatment).
The enrolment of 100 patients is statistically enough to demonstrate a decreased SOFA scores in the L-citrulline group as compared to the placebo group on day 7.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- age > 18 years
- medical patient (absence of recent surgery or trauma)
- initial aggression < 5 days
- mechanically ventilated with expected duration of mechanical ventilation > 2 days
- exclusive enteral nutrition
- absence of previous immunosuppression
- severe sepsis
- septic shock
- obesity defined as BMI above 40
- pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control group Enteral nutrition Enteral nutrition 5-day placebo treatment Control group Placebo Enteral nutrition 5-day placebo treatment L-Citrulline group Enteral nutrition Enteral nutrition 5-day L-citrulline treatment (10 grams/day) L-Citrulline group L-Citrulline Enteral nutrition 5-day L-citrulline treatment (10 grams/day)
- Primary Outcome Measures
Name Time Method Organ failure score comparison D7 At day 7 Organ failure score (SOFA score) on day 7 in the L-citrulline group as compared to the placebo group
- Secondary Outcome Measures
Name Time Method Organ failure score comparison D3 At day 3 Organ failure score (SOFA score) on day 3 in the L-citrulline group as compared to the placebo group
Plasmatic concentration of IL6 At day 7 Comparison of the plasmatic concentration of interleukin-6 between the L-citrulline group and the placebo group
Mortality during the stay in hospital, up to 28 days * Mortality in intensive care and in hospital : Comparison between the L-citrulline group and the placebo group
* Duration of mechanical ventilation.SOFA score evolution between randomisation and D7 up to 7 days Binary criterion of success or failure :
- Success is defined by: an improved SOFA score of at least 2 points from randomization to Day 7 or an improvement in the general condition yielding the release of the unit;
- Failure is defined by an improved SOFA score but less than 2 points, no improvement or worsening of the SOFA score from randomization to Day 7 or the patient's death before J7;Plasmatic concentration of L-arginine At day 7 Comparison of the plasmatic concentration of L-arginine and its metabolites between the L-citrulline group and the placebo group
Incidence of nosocomial infections during the stay in the ICU, an average of 7 days Comparison between the L-citrulline group and the placebo group
Duration of mechanical ventilation during the stay in ICU, an average of 7 days Duration of mechanical ventilation: Comparison between the L-citrulline group and the placebo group
Expression of HLA-DR At day 7 Expression of HLA-DR in the L-citrulline group as compared to the placebo group
HLA-DR At day 7 Comparison of the percentage of expression of monocytic HLA-DR between the L-citrulline group and the placebo group
Length of stay during the stay in hospital, up to 28 days Length of stay in ICU and hospital: Comparison between the L-citrulline group and the placebo group
Trial Locations
- Locations (4)
CHU Nantes
🇫🇷Nantes, France
Paris - HEGP
🇫🇷Paris, France
CHU Angers
🇫🇷Angers, France
Rennes Hospital University
🇫🇷Rennes, France